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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameACUITY SPIRAL LEAD
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namepulse generator
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP010012
Supplement NumberS264
Date Received02/24/2011
Decision Date04/07/2011
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for reassignment of a mechanical input specification, suture sleeve resistance to cut-through from the suture sleeve, to the lead body for the acuity spiral implantable lead.
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